MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 602 MODULE; IMMUNOCHEMISTRY ANALYZER

Catalog Number	09005803190
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ft3 reagent lot number is 68665600 and the expiration date is 30-apr-2024.The psa reagent lot number is 70820300.The expiration date was not provided.The field service engineer (fse) replaced the detection unit and performed mechanical checks.Calibration and qc were performed successfully.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable results for elecsys ft3 iii and elecsys total psa immunoassay for 2 patient samples on a cobas e 602 module.On (b)(6) 2023, sample 1 had an initial ft3 result of 7.58 pmol/l.On (b)(6) 2023, the sample was repeated and the repeat result was 4.29 pmol/l.On (b)(6) 2023, sample 2 had an initial psa result of 0.594 ug/l.On (b)(6) 2023, the sample was repeated and the repeat result was 0.794 ug/l or 0.793 ug/l.Clarification on which result was requested but not provided.
Additional Manufacturer Narrative
The calibration data provided was acceptable.The alarm trace showed a few sample short and abnormal sample aspiration alarms around the time of the event.Based on the available data, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: COBAS 8000 E 602 MODULE
• Common Device Name: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 17843026
• Report Number: 1823260-2023-03135
• Device Sequence Number: 4350054
• Product Code: JJE
• UDI-Device Identifier: 07613336171585
• UDI-Public: 07613336171585
• Combination Product (Y/N): Y
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 09005803190
• Device Lot Number: 15J6-06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown